Novartis Pharma AG: New Novartis data further support benefits of Kesimpta in relapsing MS following switch from oral disease modifying therapies

• ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing multiple sclerosis (RMS)following switch to Kesimpta after breakthrough disease* on fingolimod or fumarate-based therapies¹
  
  
• Following switch to Kesimpta, over 90% of people with RMS showed no evidence of disease activity (NEDA-3) and low annualized relapse rates (ARR) were observed¹
  
  
• In the separate ALITHIOS open-label extension study, more than 90% of patients receiving first-line Kesimpta were progression-free for up to seven years, reinforcing benefit of introducing Kesimpta early²
  
  

Basel, September 24, 2025 - Novartis today announced new data from two Kesimpta^® (ofatumumab) studies in relapsing multiple sclerosis (RMS) that will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting in Barcelona, Spain, on September 24-26.

Data from the ARTIOS Phase IIIb, open-label, single-arm, prospective study showed that patients who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies had a substantial reduction in disease activity, as shown by a low annualized relapse rate (ARR, 0.06 over 96 weeks)¹. The data also showed an almost complete suppression of MRI activity and over 9 out of 10 participants achieving no evidence of disease activity (NEDA-3)¹. No new safety concerns were observed following the switch to Kesimpta, irrespective of the last prior disease modifying treatment (DMT)¹.

Lead investigator Dr. Riley Bove of the University of California, San Francisco, stated, "These findings add to the growing evidence on the efficacy and safety of ofatumumab after a switch from oral DMTs. Crucially, we observed robust disease control sustained over two years in patients with RMS who did not respond well to oral DMTs."

The separate ALITHIOS open-label extension study includes recently diagnosed (=3 years) treatment-naïve (RDTN) people with RMS receiving first-line continuous Kesimpta². The study showed more than 90% achieved NEDA-3 at seven years². Long-term efficacy was measured by sustained low ARR and profound suppression of MRI activity as well as a favorable safety profile, with no new safety concerns, in both the overall population and RDTN patients^2,3.

"The long-term data from these studies underscore Kesimpta's ability to deliver sustained efficacy and a consistent safety profile for people with RMS," said Norman Putzki, M.D., Ph.D., Global Head Development, Neuroscience & Gene Therapy, Novartis. "These findings reinforce Kesimpta's position as a therapy that empowers patients to take early control of their disease."

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord⁴. MS, which affects nearly 3 million people worldwide⁵, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)⁶. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease⁴.

About Kesimpta^® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously^7-10. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional^7,8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen¹¹. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015¹². Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 92 countries worldwide with more than 150,000 patients treated as of August 2025^7,8,13.

Novartis in Neuroscience
At Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, neuroimmunology, neurodegeneration and neuromuscular/rare diseases.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com (https://www.novartis.com/) and connect with us on LinkedIn (https://www.linkedin.com/company/novartis/), Facebook (https://www.facebook.com/novartis/), X/Twitter (https://twitter.com/Novartis) and Instagram (https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$).

*In the ARTIOS Phase IIIb open-label, single-arm, prospective study, breakthrough disease activity was defined as =1 clinically reported relapse or =1 sign of MRI activity (e.g., gadolinium-enhancing T1 lesions or new or enlarging T2 lesions) while the patient was adequately using fumarate-based therapy or fingolimod prior to transitioning to ofatumumab¹.

References

1. Bove R, Langdon D, Boer I, et al. Ofatumumab Safety and Efficacy in People Living With Relapsing Multiple Sclerosis With Breakthrough Disease on Oral Fumarates or Fingolimod: ARTIOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
2. Bittner S, Hauser SL, Pardo G, et al. Continuous Ofatumumab Treatment Up to 7 Years Shows a Consistent Safety and Efficacy Profile in Recently Diagnosed Treatment-Naive People Living With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
3. Hauser SL, Bar-Or A, Cross AH, et al. Continuous Ofatumumab Treatment for Up to 7 Years Shows a Favourable Safety and Efficacy Profile in People With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
4. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317.
5. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977.
6. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/understanding-ms/what-is-ms/types-of-ms (https://www.nationalmssociety.org/understanding-ms/what-is-ms/types-of-ms) Accessed August 13, 2025.
7. Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.novartis.com/us-en/sites/novartis_us/files/kesimpta.pdf (https://www.novartis.com/us-en/sites/novartis_us/files/kesimpta.pdf) Accessed September 12, 2025.
8. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. February 2025. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf (https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf) Accessed August 20, 2025.
9. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515.
10. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27-29, 2020; West Palm Beach, FL, US.
11. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14-17, 2016; London, UK.
12. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d (https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d) Accessed August 13, 2025.
13. Novartis. Data on file.
    
    

# # #

Novartis Media Relations
E-mail: [e-mail] (mailto:[e-mail])

Novartis Investor Relations
Central investor relations line: [phone]
E-mail: [e-mail] (mailto:[e-mail])